Sr. Clinical Research Associate

About Karius

Karius is a life science, venture-backed clinical metagenomics company, focused on elevating patient care through microbial insights. We are committed to advancing diagnostic science and technology to optimize the diagnosis and treatment of infectious diseases. Through the use of genomics and AI, we are driven to improve the diagnostic landscape for infectious diseases. Karius delivers unprecedented diagnostic insight detecting microbial cell-free DNA circulating in the body to assist physicians to make rapid treatment decisions.

Position Summary

The Sr. Clinical Research Associate is responsible for advanced clinical site management and monitoring across Karius clinical programs, ensuring adherence to study protocols, ICH-GCP guidelines, sponsor procedures, and applicable regulatory requirements. Building on the full independent site ownership expected of a CRA II, the Sr. CRA manages more complex or higher-risk sites, applies advanced judgment to monitoring findings and emerging risks, and recommends corrective actions to support effective study execution. The Sr. CRA partners closely with Clinical Trial Managers and cross-functional teams and serves as a resource and mentor to less experienced Clinical Operations team members.

Why Should You Join Us?

Karius aims to conquer infectious diseases through innovations around genomic sequencing and machine learning. The company’s platform is already delivering unprecedented insights into the microbial landscape, providing clinicians with a comprehensive test capable of identifying more than a thousand pathogens directly from blood, and helping industry accelerate the development of therapeutic solutions. The products Karius offers today are some of the most advanced solutions available to physicians who aim to deliver better care to many otherwise ineffectively treated patients. Our tests are the result of some incredible work done by our scientists, statisticians, engineers, and physicians, all driven by the same mission. You, as part of the Karius team, will be able to see how directly your work has a life-changing impact on people, and at scale.

Reports to: Sr. Manager, Clinical Site Operations

Location: Remote

Primary Responsibilities

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Independently plan, conduct, and document on-site and remote monitoring visits, including site qualification visits (SQVs), site initiation visits (SIVs), interim monitoring visits (IMVs), and closeout visits (COVs), in accordance with the Clinical Monitoring Plan, study protocols, ICH-GCP guidelines, sponsor procedures, and applicable regulatory requirements.

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Apply a risk-based monitoring approach to evaluate site performance, protocol compliance, data quality, subject safety, and documentation completeness, and determine appropriate follow-up actions.

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Conduct comprehensive source data verification (SDV) and source data review (SDR) to ensure Case Report Form (CRF) data is accurate, complete, and consistent with source documentation and the study protocol.

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Independently manage day-to-day site relationships, driving enrollment momentum, query resolution, protocol compliance, timely completion of study activities, and overall site performance.

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Proactively identify, assess, and document monitoring findings, site-level risks, protocol deviations, compliance concerns, and data trends, and escalate significant or recurring issues with recommended corrective actions.

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Prepare and submit timely, high-quality monitoring visit reports and follow-up correspondence that clearly document site health, compliance status, findings, risks, required actions, and follow-up expectations.

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Track monitoring findings and action items through resolution and verify completion and effectiveness during subsequent monitoring contacts.

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Oversee the collection, review, and maintenance of essential regulatory and study documents to support ongoing inspection readiness.

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Support and lead site-level study start-up ac